Prestige Biopharma Limited  

Singapore, 
Singapore
http://www.prestigebiopharma.com
  • Booth: 14157

Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on the development of biosimilars and new antibody therapeutics. Its lead program, HD201 Trastuzumab biosimilar, is under Phase 3 clinical development and will be filed with EMA and USFDA in 2019. Prestige BioPharma´s next products in line include a Bevacizumab biosimilar (HD204) in Phase 1 and an Adalimumab biosimilar (PBP1502) and an innovative anti-PAUF mAb (PBP1510) in preclinical stages.

 Products

  • PBP1510 (INN: Ulenistamab)
    PBP1510 is a first-in-class monoclonal antibody drug developed by Prestige Biopharma Limited against pancreatic adenocarcinoma up-regulated factor (PAUF), a protein that is overexpressed in pancreatic adenocarcinoma. PAUF is involved in promoting tumor growth, invasion, and metastasis, in the evasion of immune surveillance, and contributes to the generation of an immunosuppressive tumor microenvironment (TME). Neutralization by PBP1510 attenuates the tumorigenic potential of PAUF in both the pancreatic cancer cells and TME.

    PBP1510 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) in Korea, as well as Fast Track Designation by FDA.

    PBP1510 is currently being investigated in an open-label, multi-center, Phase 1/2a clinical trial (PAUF-I; NCT05141149) in advanced/metastatic pancreatic cancer patients whose tumors have progressed on standard chemotherapy. The study underway in the U.S., Europe, Asia, and Australia, aims to assess the safety, efficacy, tolerability, pharmacokinetics (PK), and immunogenicity of PBP1510.
     ...

  • Tuznue™(Trastuzumab biosimilar)
    Tuznue™ is a biosimilar of Herceptin® (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue™ is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC).

    Tuznue™ has been granted Marketing Authorisation by the European Commission (not approved in the U.S.)....

Categories

Cancer Types
  • Breast Cancer
  • Gastrointestinal (Noncolorectal) Cancer
    • Categories:
  • Antibodies
  • Drug Development
  • Pharmaceutical
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